Prospective clinical study aiming at the improvement of hepatic encephalopathy and hepatic functional reserve of patients with liver cirrhosis by the secretory laxative agate lubiprostone
- Conditions
- hepatic encephalopathy
- Registration Number
- JPRN-UMIN000040157
- Lead Sponsor
- ara Medical University Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Not provided
1. <=19 y.o. or 81 y.o.<= 2. pregnancy or breast-feeding 3. have ever taken lubiprostone 4. heart failure (admission by 6 months) 5. renal severe failure(eGFR<30 ml/min/1.73m2) 6. serum sodium <125mEq/L or >150mEq/L 7. Cerebral infarction without paralysis and lacunar infarction 8. Dementia more than Performance Status 2 9. abdominal surgery career (stomach segmental resection or intestinal tract excision) 10. with taking opioid agents 11. change or increase diuretic agents for obserbation period 12. with infectious disease or gastrointestinal breeding 13. with malignant tumor 14. patients of refusal this trial 15. The patient who judged that this study responsibility doctor and allotment doctor were inadequate
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following is the measurement, an item evaluating at point of start, 1, 3, 6 months. serum NH3
- Secondary Outcome Measures
Name Time Method The following is the measurement, an item evaluating at point of start, 1, 3, 6 months. Blood exams; Blood count, prothrombin time, various blood biochemistry [Alb, AST, ALT, ALP, gamma-GTP, T-Bil, Cre, CRP, NH3], endotoxin-related marker (EAA, CD163, CD206) Simple inspection: Number connection test, Stroop test, CLD questionnaire with or without adverse event, stool frequency and status (ever average of 2 weeks), the weight change. It is an item to evaluate at six months at the point of start as follows. An examination for feces: An enterobacterial flora change, feces organic acid analysis. Confirm the following items by ELISA (TNF-alpha, IL-6, IL-12, IL-10, TGF-beta).